Drug firm corruption

The news of mass corruption charges against staff at GlaxoSmithKline's (GSK) Italian subsidiaryfilia two weeks ago caused a furor in this country's national media.

Within days, both a doctor and an employee of a foreign-owned, it was emphasized, pharmaceuticalfarmaceutyczny concern appeared in both print and TV media, testifyingto testify: zeznawać that they had witnessed illegal marketing practices on the local market. Journalists also turned to ex-health ministry officials for authoritativewiarygodny comment, dulynależycie, właściwie obtaining piousnabożny (tutaj - zakłamany) expressions of regret and disapproval.

In other EU member states, though, the GSK scandal received little attention, even in business and financial publications. Much more interest was, and is, being paid to GSK's other legal travailstrudy, mozół in New York, which have potentially far more significant repercussions for both the industry and consumers. The state of New York has taken GSK to court in relation to its selective publication of clinical trialpróba results, with the allegedrzekomy, domniemany aim of concealingto conceal: ukrywać the negative effects of anti-depressant drugs for children.

So why the local media hyperobić szum about a three year-old scandal in Italy? Cynics point to the coincidencezbieg okoliczności that the scandal involving innovative pharmaceuticalfarmaceutyczny companies hit the press shortly before the compilationzestawienie of the latest government reimbursement listlista leków refundowanych. Whether or not there is any significance in this serendipitydar dokonywania przypadkowych odkryć, it can't be denied that a bad press for innovative companies can only be to the advantage of the health ministry, which, uniquely within the EU, has excluded new medicines from the list for six years now, despite the fact that such medicines can often mean the difference between a normal existence and hospitalization for thousands of citizens.

Which is not to say that the pharmaceuticalfarmaceutyczny industry in this country isn't corrupt. By all reports, it is. Last year, the FBI launched a probedochodzenie into allegedrzekomy, domniemany briberyprzekupstwo, łapownictwo by U.S. pharmaceuticalfarmaceutyczny firms in Poland. Meanwhile, market insiderswtajemniczeni claim that at least one smallish foreign subsidiaryfilia on the local market, though it conducts genuineautentyczny, prawdziwy clinical trials elsewhere, also pays doctors to conductprzeprowadzać extra shamfałszywy, pozorowany clinical trials on the domestickrajowy market in order to both win over doctors and introduce its drugs to potential consumers. Industry insiderswtajemniczeni also suggest that, to put it delicately, the creative interpretation of the law on druglek promotion is common practice throughout the domestickrajowy industry, among both locally- and foreign-owned concerns.

It's hardly surprising, then, that prestigious daily Rzeczpospolita ran a story in response to the Italian GSK scandal, proclaiming, "The pharmaceuticalfarmaceutyczny sector is sick." What is surprising, though, is that the paper could conclude, without a traceślad of irony, that "against the phenomenon, the state remains helpless."

The overwhelmingprzytłaczający majority of corruption scandals on the pharmaceuticalfarmaceutyczny market have involved government officials themselves. In May 2003, it was revealed that a Romanian concern had got a druglek registeredto register: rejestrować in the space of just three months on the basis of 'clinical trials' that had allegedly taken place on a small group of people conducted on property owned by a government official. A further 200 suspiciously speedy druglek registrations by local and CEE generic companies under the health ministry of Łapiński remain - mysteriously - uninvestigated. Also in May last year, a government official was accused by a foreign corporation of attempting to extortwymuszać, wyłudzać an enormous bribełapówka in return for placing drugs on the reimbursement listlista leków refundowanych. His trialpróba continues.

Pharmaceuticals is the one industry where the government, as well as regulating it, is also by far the most significant customer. Since funding health care is a problem for all government budgets, and apparently particularly difficult for Polish ones, governments have a powerful vested interestżywotny interes in securing the cheapest possible drugs that, unless checked, they're bound tosb is bound to do sth: ktoś na pewno coś zrobi abuse.

Legislation guiding decisions as to which medicines are included on the reimbursement listlista leków refundowanych in this country is confusing. It is also constructed so that there's no effective process of appeal over reimbursement decisions before they become law, much less any effective channel of bringing the government to account afterwards. Meanwhile, since 2003, the minister responsible for reimbursement decisions also supervisesto supervise: nadzorować the registration authority. This, say industry insiderswtajemniczeni, made the spate ofseria/fala czegoś suspicious registrations under Łapiński singularlyjedynie easy to accomplishosiągnąć, zrealizować.

As lawyers and doctors - but, notablyw szczególności, zwłaszcza, rarely the media - report, the government habitually cheats thousands of this country's poorest and most helpless citizens by including on the reimbursement listlista leków refundowanych generic copies that do not cure all the disorders cured by the originals that they are said to substitutezastępować. The list also includes drugs that are either not availabledostępne or, because of patent infringementnaruszenie cases, should not be legally availabledostępne, as well as drugs whose registration processes are in question.

This enables the government to pretend that spending on drugs is down, when all that is actually down is the budget's contributionwkład, udział. Those citizens who are sick and need drugs other than the ones they can get significantly subsidizedto subsidize: dotować in drugstoresdrogerie simply have to fork outwybulić from their own pockets. Yet despite the fact that they dramatically affect hundreds of thousands of citizens, the national media, say lawyers and doctors, have mostly shown a curiousdziwny, zastanawiający aversion to investigating these issues.

A recent article in Businessweek, for example, claimed that "the only difference between originals and generics is price." Though in some cases this may be true, in many crucial cases it is not.

These problems would be addressed, and shadypodejrzane practices would be harder for the government to keep hidden, if the government implementedto implement: wprowadzać w życie EU transparencyprzejrzystość directive 89/105/EEC as it should have done long ago. However, the 'helpless' government has, as yet, shown no great eagernesschęć to do so.

Agnieszka Deeg-Dąbrowska, partner at international lawyers Cameron McKenna, thinks the lack of a transparent policy directing government reimbursement decisions, together with the lack of any effective channels to dispute those decisions, creates a situation where being on the reimbursement listlista leków refundowanych depends, to a great extent, on gaining the favor of relevantstosowny officials.
She suggests a second problem is one of, shall we say, less than comprehensive enforcementegzekwowanie of the laws that do exist regarding druglek registration and reimbursement.

"To my knowledge, none of the local companies involved in the spate ofseria/fala czegoś suspicious registrations under Łapiński has yet been called to accountto call sb into account: żądać od kogoś wyjaśnień in the courts," she says.

"The government reimbursement lists offer at least two local generic drugs as equivalent therapies to originals when, for thousands of patients suffering from chronic illnesses, medically they are not equivalent as to efficacyskuteczność or indicationsoznaki," says Paulina Kieszkowska, an international lawyer at Baker & McKenzie. But the local media prefer to promote the patriotic myth that corruption within the industry is confined toograniczony do foreign-owned, and particularly innovative, companies.

When local pharmaceuticalfarmaceutyczny concern Adamed was ordered by the chief pharmaceuticalfarmaceutyczny inspector (GIF) to stop advertising a druglek as an equivalent for all the indicationsoznaki of a Novartis druglek, the fact went unreported. And when Novartis, the Swiss giant, initiated legal proceedings against Adamed for continuing to market the druglek in defiance of the ruling, the daily press didn't bother reporting that either. Then the GIF reframedto reframe: sformułować ponownie its order and said that Adamed could market the druglek, but only as a cure for those indicationsoznaki for which it actually has the medical credentialskwalifikacje to cure. This, and only this last part of the saga, immediately hit the national papers, and in a curiousdziwny, zastanawiający form. Polish pharmaceuticalfarmaceutyczny company Adamed had begun court proceedings against foreign Novartis, the story ran, for unjustly blackeningto blacken: oczerniać it's reputation among doctors.

The transparencyprzejrzystość directive, though, would be of little use in stopping pharmaceuticalfarmaceutyczny companies from either misinformingto misinform: wprowadzać w błąd or bribing doctors through illegal promotion practices. Although more transparent reimbursement decisions would, indirectly, reduce the number of cases, such as the Adamed/Novartis one, how to ensure that patients don't find themselves coughing upto cough up: wybulić for prices hiked upto hike up: podwyższać by illegal perksuboczne/dodatkowe korzyści for doctors is another issue. Though undoubtedly serious, it is one which, judging by the comments of some ex-ministers, shouldn't be left to politicians to settle, at least not at any time near the next elections.

Asked how to combat corruption, ex-minister Marek Balicki, for example, seemed to suggest that one way to prevent companies from forking out on bribes was simply to cut backograniczać their profit margins. The official druglek price is the maximum price, which means companies can offer warehouseswarehouse: hurtownia, magazyn and drugstoresdrogerie discountszniżki, ulgi. The fact that pharmaceuticalfarmaceutyczny companies are able to offer, like most businesses, discountszniżki, ulgi on scale to distributors, Balicki appeared to say, means that companies are making too much money and ought bow toto bow to sth: pogodzić sie z czymś government demands to lower prices. He concluded that the official price of a druglek should be inflexible. While completely irrelevant to the issue of corruption, his arguments are very relevantstosowny to the elderly vote in the upcoming polls.

"You have to remember that under communism there was a command economy and no drugs marketing. And all drugs - though often very bad drugs - were at least free," says Andrzej Trzeciakowski, general director of Hexal Polska, the local branch of the German generics producer.

"There is a tendency, encouraged by the government, to see pharmaceuticalfarmaceutyczny companies as obliged tozobowiązane do guarantee access to modern treatment at their cost," says Kieszkowska. This despite the fact that it's clearly the government, not the businesses, that under the reimbursement scheme is obliged tozobowiązane do co-pay with the patient.

There is also a strong body of opinion in this country that seems to think pharmaceuticalfarmaceutyczny companies shouldn't be able to market their products at all, or even to make any kind of profit, according to Treciakowski, who recently called for an ending of misinformed demagoguerydemagogia against foreign pharmaceuticalfarmaceutyczny concerns in the press.

"We have been called bloodsuckerskrwiopijcy, thieveszłodzieje and any number of other things by the national press," he says. "But all we're doing is trying to make a profit in a competitive marketkonkurencyjny rynek. We have to compete for clients and justify performance to shareholdersakcjonariusze, udziałowcy, just like any other business!"

Despite popular perceptions, the fact is that the problem is not that pharmaceuticalfarmaceutyczny firms market aggressively and offer lavishszczodry, hojny patronage, but the way in which they do it.

According to the Association of Foreign Pharmaceutical Representatives (SPFFwP), the distinctionsróżnice between what is legal and what is not are very clear. The rules, says its spokespersonrzecznik, rzeczniczka, are both "transparent and restrictive." The problem is, "traffic regulations don't ensure that drivers won't break the law," as he puts it.

Kieszkowska, however, is less sure that checkskontrole on the nature of pharmaceuticalfarmaceutyczny sponsorship are adequately institutedto institute: wszczynać.

"A lot in the law is widely open to interpretation," she says. Pharmaceutical companies are allowed, for example, to sponsor medical congresses, a set-uporganizacja intended to direct their funds towards enablingto enable sb to do sth: umożliwiać komuś zrobienie czego doctors to keep up with industry developments. But there is clearly a broad range as to the 'usefulness' of all the congresses convenedto convene: zwoływać.

While in some European countries pharmaceuticalfarmaceutyczny companies have to inform medical authorities in detail about congresses organized for doctors, in Poland they don't. Meanwhile, the GIF has so far shown little interest in examining congresses. And, on its past record, the GIF can't necessarily be relied on not to control the issue very selectively.

A lack of adequate, objective enforcementegzekwowanie affects other areas of the pharmaceuticalfarmaceutyczny law on druglek promotion as well. According to an ex-doctor quoted in the national press, one dodgyśliski (= ryzykowny) promotion technique involves companies accessing drugstore data systems that keep records of which doctor has prescribed which drugs. This makes it possible, she says, for pharmaceuticalfarmaceutyczny companies to reward doctors who prescribeprzepisywać their drugs with an alarming degree of accuracy.

One proposal mootedto moot: poddać pod dyskusje is to create a national database amassedto amass: gromadzić from the aforementionedwyżej wymieniony pharmacy records so as to enable law enforcers to tot upto tot up: zliczać, sumować exactly who's prescribing what. Accompanying this should be a reference guide, compiled free from government meddlingto meddle: wtrącać się, of the recommended therapies and therapeutic procedures for every known complaint. But even this would not be enough, insiderswtajemniczeni warn. There also needs to be some effective implementation system to securezabezpieczyć against selective law enforcementegzekwowanie. And also against the government using the information to put illegal pressure on doctors not to prescribeprzepisywać the more expensive choices on the reimbursement listlista leków refundowanych, which, lawyers report, the government recently tried to do after a raidnalot on pharmacy databases.

Such reforms may help nipto nip in the bud: zdusić w zarodku government intrigues in the bud, and stop companies practicing local variations of the dodgyśliski (= ryzykowny) marketing practices unearthedto unearth: ujawniać in Italy. But there remains the worldwide issue of the vulnerabilitypodatność of patients to manipulation by interested parties and of druglek information raised by the GSK case in New York.

Increasingly, the wisdommądrość of a global convention wherein pharmaceuticalfarmaceutyczny companies are allowed to pay doctors to conductprzeprowadzać what are meant to be objective clinical trials and control trialpróba result publication is being questioned.

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